bioMetric SpinalPak - Page 15

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Guidance and manufacturers declaration - electromagnetic immunity
TheBiomet
®
SpinalPak
®
Non-invasiveSpineFusionStimulatorSystemisintendedforuseinthe
electromagneticenvironmentspecifiedbelow.ThecustomerortheuseroftheBiomet
®
SpinalPak
®
Non-invasiveSpineFusionStimulatorSystemshouldassurethatitisusedinsuchanenvironment.
Immunitytest
IEC 60601
testlevel
Electromagneticenvironment-
guidance
Electrostatic
discharge(ESD)
IEC 610004-2
± 6 kV contact
±8kVair
Floorsshouldbewood,concreteor
ceramictile.Iffloorsarecoveredwith
syntheticmaterial,therelativehumidity
shouldbeatleast30%.
Electricalfast
transient/burst
IEC 61000-4-4
NotApplicable
Surge
IEC 61000-4-5
Notapplicable
Voltagedips,short
interruptionsand
voltagevariations
onpowersupply
inputlines
IEC 61000-4-11
Notapplicable
Powerfrequency
(50/60Hz)
magneticfield
IEC 61000-4-8
Notapplicable
Compliancelevel
Group 1
Class B
Notapplicable
Notapplicable
Notapplicable
Table 2